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Recombinant activated protein C (APC; also known as drotrecogin alfa, brand name Xigris) has shown clinical efficacy for the initial treatment of adults with severe sepsis and is used in many intensive care units. APC often is given to pediatric patients with septic shock, even though its safety and efficacy in this population have not been established. APC increases the risk for bleeding in patients of any age; therefore, contraindications include a low platelet level, disseminated intravascular coagulopathy, active bleeding from any site, and recent or imminent surgery.
On April 28, 2005, the FDA and APC’s manufacturer announced the discontinuation of a randomized, placebo-controlled trial of APC in pediatric patients with severe sepsis (h…